Working to Increase Stability Through Exercise

NCT ID: NCT02714257

Last Updated: 2025-02-05

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 1139 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2016-11-21
• Study Completion Date: 2021-12-17

Brief Summary

The investigators propose a 36-month multi-center randomized effectiveness trial to compare the impact of an Enhanced Usual Care (Control) intervention, with Exercise Coaching (Exercise), on Fragility Fractures and Serious Fall-Related Injuries (FF/SFRI) in patients with a previous fragility fracture (FF).

The investigators will also examine the impact of the intervention on several secondary outcomes like: loneliness, physical function, and bone strength. The investigators will do this by following a Pragmatic trial design: 1) limiting exclusions to increase representativeness, 2) limiting research contacts (average 30 min/year) and 3) limiting measures to those practicable for use in usual care.

Detailed Description

The intervention will be held in churches, community centers, and senior residential facilities. Investigators will work with the exercise sites to recruit up to 125 individuals (5 per exercise site location) to serve as the Group leaders at each site location. Group leaders will be trained on the exercises and leadership roles to help lead the group. The investigators will ask them to come at least once per week, so the time commitment is minimal.

The investigators will be recruiting 1130 patients who have suffered a fragility fracture and will randomly assign them to one of two conditions: (A) Control Group - Enhanced Usual Care and (B) Intervention Group - Enhanced usual care plus Exercise coaching that includes in-person and phone coach contacts to encourage and support strength, balance and walking activities.

*Due to the COVID-19 pandemic, the in-person intervention was stopped in March of 2020 and a Zoom-based virtual intervention was introduced in April of 2020. Participants that join the zoom-based virtual intervention are lead by staffed exercise coaches.

Conditions

Fractures, Bone

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: NONE

Study Groups

Enhanced Usual Care - control group

Participants will receive enhanced usual care by reviewing three printed pamphlets on fall risks and recommendation to exercise. In addition, to maximize patient safety, the investigators will communicate the baseline bone density results (measured by Dual-energy X-ray absorptiometry, DXA) to the patient's primary care provider, and any critical values of a baseline measure.

Group Type: NO_INTERVENTION

No interventions assigned to this group

Enhanced Usual Care plus Exercise Coaching Intervention

Participants will receive the three printed pamphlets on fall risks and exercising in groups (same as the controls) plus: (1) an exercise program that includes strength, balance, and aerobic exercises; (2) an exercise coach that provides in-person and telephone support/feedbacks to enhance participation in the exercise program; and (3) regular progress reports sent by coaches by fax/Electronic Health Records every 4 months, to communicate the patient's progress.

Group Type: EXPERIMENTAL

Enhanced Usual Care plus Exercise Coaching

Intervention Type: BEHAVIORAL

For month one of the exercise intervention the investigators will conduct only strength and a few balance exercises to rehabilitate the participants. After the first month, and once the participants feel comfortable, the investigators will incorporate aerobic and additional balance exercises. The investigators will personalize participant programs based on baseline levels and increase them gradually. The exercise session will be conducted 50 minutes 3 times a week. Between sets there is a 60-second break.

Every month the coach will record steps from the pedometer and record patient adherence to exercise sessions, and every 2 months the coach will measure strength and will track resistance band color from the exercise trackers.

For the individuals exercising at home, the investigators will distribute the exercise Digital Versatile Disc (DVDs) every 9 months and the coach will continue to contact them, just as if they were joining the group. Coaches will encourage group participation.

Interventions

Enhanced Usual Care plus Exercise Coaching

For month one of the exercise intervention the investigators will conduct only strength and a few balance exercises to rehabilitate the participants. After the first month, and once the participants feel comfortable, the investigators will incorporate aerobic and additional balance exercises. The investigators will personalize participant programs based on baseline levels and increase them gradually. The exercise session will be conducted 50 minutes 3 times a week. Between sets there is a 60-second break.

Every month the coach will record steps from the pedometer and record patient adherence to exercise sessions, and every 2 months the coach will measure strength and will track resistance band color from the exercise trackers.

For the individuals exercising at home, the investigators will distribute the exercise Digital Versatile Disc (DVDs) every 9 months and the coach will continue to contact them, just as if they were joining the group. Coaches will encourage group participation.

Intervention Type: BEHAVIORAL

Eligibility Criteria

Inclusion Criteria

• ≥ 65 years old
• Previous Fragility Fracture (FF) in past 10 years.
• Able to speak and understand English.
• Participants will need to be willing to try exercising and agree to annual follow-up measurements.

Exclusion Criteria

If the answer to the following questions are "yes", the investigators will exclude the participant from the study Do you feel pain in your chest, neck, jaw, or arms at rest, during your daily activities of living, OR when you do physical activity? Have you ever been told by a health professional that you should not exercise OR exercise only when supervised by a professional?

If the answer to the following questions are "yes", the investigators will contact physician for permission Do you experience unpleasant awareness of a forceful or rapid heart rate? Do you experience unreasonable breathlessness? Do you experience dizziness fainting or blackouts? Do you experience ankle swelling? Do you have burning or cramping sensation on your lower legs when walking short distances? Do you have diabetes?

Has a doctor, nurse or health professional ever told you that you had any of the following? Weak or failing kidneys? A heart attack, also called a myocardial infarction? Angina or coronary heart disease? A stroke? Any kind of heart condition or heart disease other than the ones I just asked about?

Unable to obtain primary care provider consent (if required based on questions above)

If the participant answer "NO" to the following question: Is it ok if the investigators contact your primary care provider?

If the participant answer "YES" to the following question:Have you been hospitalized for psychiatric problem in past year?

If the participant is planning on moving out of the area in the next 36 months

If currently participates in the Band Together exercise program

Positive Callahan cognition screener: If participant fails 2 questions, research coordinator will explain study in detail and ask read-back questions. The participant will be excluded if failed read-back.

• Minimum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Patient-Centered Outcomes Research Institute

OTHER

Sponsor Role: collaborator

University of Pittsburgh

OTHER

Sponsor Role: collaborator

Temple University

OTHER

Sponsor Role: collaborator

Johns Hopkins University

OTHER

Sponsor Role: collaborator

Columbia University

OTHER

Sponsor Role: collaborator

University of Illinois at Chicago

OTHER

Sponsor Role: collaborator

Milton S. Hershey Medical Center

OTHER

Sponsor Role: lead

Responsible Party

Christopher Sciamanna, MD, MPH

Prof. Medicine and Public Health Sciences, Division Chief Population Health Research and Development

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Christopher Sciamanna, MD, MPH

Role: PRINCIPAL_INVESTIGATOR

Milton S. Hershey Medical Center

Locations

Penn State Hershey Medical Center

Hershey, Pennsylvania, United States

Countries

United States

Provided Documents

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Document Type: Informed Consent Form

View Document

Other Identifiers

PCS-1406-18325-EXT

Identifier Type: OTHER

Identifier Source: secondary_id

IRB-3576

Identifier Type: -

Identifier Source: org_study_id